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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001615-23 | EudraCT Number | EudraCT |
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In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 144807 | Experimental | Subjects receive multiple BID doses of BI 144807 solution |
|
| Placebo | Placebo Comparator | Subjects receive multiple BID doses of Placebo solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 144807 | Drug | multiple dose (bid) |
| |
| BI 144807 |
| Measure | Description | Time Frame |
|---|---|---|
| Number (% patients) of drug-related adverse events | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma after first dose (Cmax) | up to 24 hours after first dose | |
| Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss) | up to 72 hours after last dose |
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Inclusion criteria:
1. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)
Exclusion criteria:
1. Apart from mild asthma any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1313.2.44001 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
multiple dose (bid, low to high dose) |
|
| Time from first dosing to maximum measured concentration (Tmax) | up to 24 hours after first dose |
| Time from last dosing to maximum measured concentration (Tmax,ss) | up to 72 hours after last dose |
| Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2) | up to 24 hours after first dose |
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss) | up to 72 hours after last dose |
| Terminal half-life of the analyte in plasma after the first dose (t1/2) | up to 24 hours after first dose |
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | up to 72 hours after last dose |
| RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose) | up to 72 hours after last dose |
| RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose) | up to 72 hours after last dose |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |